| Device |
infant positioner, rx, use in highly monitored setting |
| Regulation Description |
Pediatric position holder. |
| Definition |
Designed to position the baby at a 30 degree angle in the prone (on his/her stomach) position for specific medical or surgical conditions.For use only when in a highly monitored setting with continuous cardio-respiratory and oxygen saturation monitoring. |
| Physical State |
DEVICE MAY BE WEDGE SHAPED TO MAINTAIN THE INFANT AT A 30 DEGREE ANGLE. MAY ALSO HAVE A COMPONENT THAT IS USED TO HELP MAINTAIN THE INFANT ON THE POSITIONER SUCH AS A BINDER. |
| Technical Method |
MAINTAINS INFANT IN A DESIRED POSITION. |
| Target Area |
WHOLE BODY. |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | OUW |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.5680
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
